Is the QA/RA Consultant role remote?

It's hybrid — Ketryx expects some on-site time in Boston, Massachusetts, United States.

What's the salary range?

Ketryx lists $130,000–$150,000 for this role.

How much experience is required?

5–8 years of relevant experience for this QA/RA Consultant role.

Where is the role based?

Ketryx is hiring for this position in Boston, Massachusetts, United States.

What's the tech stack?

Joblaze extracted these technologies from the posting: Computer software validation, Cybersecurity, ISO 13485, MDSAP, Quality Management System (QMS), Regulatory consulting.

What seniority level is this role?

Ketryx targets senior candidates for this position.

Is this full-time or contract?

Full-time for this QA/RA Consultant role at Ketryx.

QA/RA Consultant at Ketryx

Joblaze summary

In the role of QA/RA Consultant at Ketryx, the individual will spearhead the implementation of quality management systems and regulatory compliance strategies for medical device clients, utilizing an innovative AI-powered platform. Key skills include expertise in ISO 13485 and experience with eQMS implementation, alongside a strong background in the medical device industry. This position is ideal for a strategic yet hands-on professional with 5-8 years of relevant experience, particularly those who thrive in high-growth environments and are passionate about regulatory excellence.

Joblaze insights

Listed 9 days ago on Joblaze — tracked directly from Ketryx's career page.
Ketryx has 11 other open roles including Delivery and Success Associate - Enterprise, Product Manager , Delivery and Success Associate.
335 active Cybersecurity roles on Joblaze right now.
11 active ISO 13485 roles on Joblaze right now.
Salary band is in line with the typical range for QA roles (median ~$130,000).
Pays more than 30% of the 165 salaried Cybersecurity roles we track (median $165,000).

Quick facts

Is the QA/RA Consultant role remote?: It's hybrid — Ketryx expects some on-site time in Boston, Massachusetts, United States.
What's the salary range?: Ketryx lists $130,000–$150,000 for this role.
How much experience is required?: 5–8 years of relevant experience for this QA/RA Consultant role.
Where is the role based?: Ketryx is hiring for this position in Boston, Massachusetts, United States.
What's the tech stack?: Joblaze extracted these technologies from the posting: Computer software validation, Cybersecurity, ISO 13485, MDSAP, Quality Management System (QMS), Regulatory consulting.
What seniority level is this role?: Ketryx targets senior candidates for this position.
Is this full-time or contract?: Full-time for this QA/RA Consultant role at Ketryx.

From the original posting

Job Title: QA/RA Consultant
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)

As a Ketryx QA/RA Consultant, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world’s most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform.

Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices.

This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option).

About You:

You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining.

Responsibilities:

Lead Quality Management System (QMS) setup and deployment for medical device clients.
Own and manage QMS templates and regulatory compliance frameworks.
Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.
Scale operations to support high-growth clients.
Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
Shape the future of regulatory affairs through innovative product development.
Work independently on complex quality assurance projects requiring minimal oversight.
Ensure customer success across the entire customer engagement lifecycle.

Required Skills:

4-8 years of experience in quality systems management, management representative or senior specialist role.
Familiar with eQMS implementation, validation and implementation.
Deep expertise in Quality Management System setup, sub-systems, and implementation.
Strong knowledge of ISO 13485 and Global QMS requirements.
Expertise in AI, Digital, and Cyber Compliance.
Deep understanding of medical device cybersecurity.
Experience as quality management representative in regulated environments.
Experience with regulatory and Notified Body submission requirements.
Background in medical device industry quality systems.
Ability to work independently and own complex regulatory projects.
Proven track record in consulting or client-facing roles.

Preferred Skills:

Experience at large medical device companies (Stryker, Medtronic, Boston Scientific).
Background with consulting firms specializing in QMS setup.
Startup experience (Series A/B) with QMS implementation.
Specializations in cybersecurity, usability, or computer software validation.
Experience scaling quality operations in high-growth environments.
Knowledge of AI applications in regulatory affairs.
Submission experience.
Experience working in an early stage, product-based start up.

Keywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry

What We Offer

Competitive compensation
Generous stock options possible
Work in an exciting field with a positive impact on the world
Opportunity to learn and grow as part of a global team
Generous PTO for full-time

Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster.

Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!